P30-EPS / Duke University, National Cancer Institute - LARVOL DELTA

Peptide-based tumor-associated antigen vaccine in glioblastoma: Correlative results of the ETAPA Phase I clinical trial (AACR 2026) - P1 | "This design aims to broadly recruit CD4⁺ T-cell help and augment cytotoxic responses. Adults with newly diagnosed, MGMT-unmethylated GBM (n = 18) received seven post-radiation intramuscular vaccinations with Hiltonol (20 µg/kg) and either 300 µg (n = 6) or 400 µg (n = 12) of P30-EPS. ETAPA achieved its primary objectives, demonstrating safety and correlative findings indicating that a universal CD4⁺ helper epitope can enhance cytotoxic and memory responses in GBM. Integration of PBMC scRNA/TCRseq with tumor ST and SP profiling will define intratumoral correlates of systemic vaccine-induced immunity. These insights now support development of our next epitope-linked personalized vaccine for patients with glioblastoma."

Clinical • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • BIRC5 • CCR7 • CD8 • IFNG • MGMT

P30-EPS peptide vaccine is safe and immunogenic in newly diagnosed glioblastoma: a phase 1b trial (EANO 2025) - "Adjuvant temozolomide was omitted, and instead patients received intramuscular P30-EPS, 300 mg (n=6) in the first cohort and 400 mg (n=12) in the second cohort, scheduled in “priming” and “booster” phases to enhance the expansion of vaccine-specific T cells. P30-EPS administered with Hiltonol demonstrated a favorable safety profile and elicited vaccine-specific immune responses in patients with newly diagnosed glioblastoma. The 400 mg dose was associated with stronger immunogenicity and early signals of clinical activity. We will present clinical outcomes, including survival and MRI responses for all 18 patients, along with longitudinal 5′ scRNA VDJ TCR profiling of PBMCs and paired baseline and on-treatment tumor snRNA-seq."

IO biomarker • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • BIRC5 • CD4 • CD8 • IFNG • MGMT

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Recruiting ➔ Active, not recruiting | N=36 ➔ 24

Enrollment change • Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • BIRC5 • MGMT

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • BIRC5 • MGMT

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Initiation date: Nov 2022 ➔ Feb 2023

Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • BIRC5 • MGMT

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Initiation date: Jul 2022 ➔ Nov 2022

Trial initiation date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • BIRC5 • MGMT